Understanding brain changes in patients with neurotoxicity from CAR T-cell therapy
Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome
This study is trying to understand how CAR T-cell therapy affects the brain in patients who develop neurotoxicity, by looking at brain scans and certain chemicals in their spinal fluid.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hebei Medical University Academic / other |
| Drugs / interventions | CAR T, CAR-T |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Trial ID | NCT05643092 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the brain mechanisms disrupted in patients experiencing Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) following CAR T-cell therapy. It will measure levels of catecholamines in cerebrospinal fluid and utilize multimodal magnetic resonance imaging to assess brain changes in these patients. By identifying specific biomarkers and imaging characteristics associated with ICANS, the study seeks to enhance detection and prevention strategies for this complication.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled to receive CAR T-cell treatment.
Not a fit: Patients who have previously undergone CAR T-cell therapy or have significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and management of neurotoxicity in patients undergoing CAR T-cell therapy.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated the importance of understanding neurotoxicity in CAR T-cell therapy, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must be ≥ 18 years of age at signing of informed consent. * Subjects are scheduled to receive CAR T-cell treatment. Exclusion Criteria: * Refusal to sign the informed consent * Subjects having previously been treated with CAR-T therapy. * Subjects with clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding * Subjects presenting primary CNS lymphoma * Pacemaker or other implanted electrical device incompatible with the MR environment * Subjects with a neurodegenerative disease (PD, AD) * Subjects with a previous or evolving neurological pathology * Pregnant or breastfeeding women
Where this trial is running
Shijiazhuang, Hebei
- 980th Hospital — Shijiazhuang, Hebei, China (Recruiting)
Study contacts
- Principal investigator: Shoulong Zhang — 980th Hospital
- Study coordinator: Shoulong Zhang
- Email: longer_human007@126.com
- Phone: 86-0311-98224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.